Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to test a specimen from an anonymous or directed reproductive donor of cells or tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)]. For example, anonymous oocyte donor **(b)(6)** was not tested for human immunodeficiency virus, type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) by the **(b)(4)** method. HCT/Ps were recovered from this donor on April 15, 2024, and transferred to a recipient.
Passage 2Failure to screen a donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)(1)]. FDA’s regulations at 21 CFR 1271.3(s) define the term “relevant medical records” to include a current medical history interview and a current report of the physical examination of a living donor. For example:
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271
- 21 CFR 1271.60(a)
- 21 CFR 1271.155
- 21 CFR 1271.85(a)
- 21 CFR 1271.75(a)(1)
- 21 CFR 1271.3(s)
- 21 CFR 1271.75
- 21 CFR 1271.80
- 21 CFR 1271.85
- 21 CFR 1271.50(a)
- 21 CFR 1271.3(h)
- 21 CFR 1271.65(b)(2)
- 21 CFR 1271.45
- 21 CFR 1271.47(a)
- 21 CFR 1271.90(b)
- 21 CFR 1271.90(c)